Natera’s Signatera™ Test Receives CE Mark
Supports clinical use and implementation of global clinical trials
SAN CARLOS, Calif., Aug. 26, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that it has received the CE mark for the Signatera test, a personalized, tumor-informed ctDNA assay optimized for molecular residual disease (MRD) assessment and treatment monitoring in patients previously diagnosed with cancer. With the CE mark, Natera can now make Signatera available to clinics and hospital systems throughout Europe to support patient management and clinical research.
"Signatera represents a significant leap forward in how we treat cancer patients in the adjuvant, neoadjuvant, and metastatic settings," said Andrés Cervantes, MD, PhD, professor of medicine and head of the department of Medical Oncology at the University Hospital, University of Valencia, Spain. "We look forward to incorporating this technology into MRD-guided clinical trials and into clinical practice across a variety of solid tumor types."
Europe has approximately one quarter of all cancer cases diagnosed globally, with some 3.7 million new patients per year, according to data from the World Health Organization (WHO) Regional Office for Europe.1
"Obtaining the CE mark for Signatera is an important step in making personalized ctDNA testing available globally, for both research and clinical use," said Solomon Moshkevich, general manager of oncology at Natera. "To our knowledge, this is the first bespoke assay to ever receive the CE mark, a testament to the strength of our scientific and regulatory teams, and a milestone in our journey to making Signatera a standard of care for cancer management worldwide."
Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera’s test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350
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- Data and statistics. World Health Organization Regional Office for Europe. https://www.euro.who.int/en/health-topics/noncommunicable-diseases/cancer/data-and-statistics.
SOURCE Natera, Inc.